Quite to my surprise Biogen actually wrote back today about my note. I’ve posted the response from Anissa.Kalinowski (Anissa.Kalinowski@biogenidec.com) below. On a unrelated note they are actually using an older version of Lotus Notes that we are v.5.0.6a! 😉

Erik,

I understand your frustration and wanted to reach out to you to reassure you that we, too, would like to ensure that Antegren data is disseminated in as timely a manner as possible.

We understand that patients like you and their neurologists would like to begin evaluating the data to see if Antegren might be the right drug for them. It was after conversations with the FDA and the clinical investigators who are managing the clinical trials that we made the decision not to release the data. Again, the primary objective was that we do not compromise the outcome of the trial – protecting the closure of the trial is an important element to ensure the data will be reviewed by the FDA objectively so that Antegren can be considered for approval. If it were possible to both share the data and ensure that this wouldn’t jeopardize approval for the product, please know that we would have certainly done both.

Should you wish to receive updates regarding the approval status of Antegren over time, please call MSActiveSource at -1800-456-2255 or visit their website at www.msactivesource.com. If you do not already receive updates from them, they can ensure that you receive such update in the future.

Please let me know if there are any other questions you might have, or if there is any other way I can be of assistance.

One Response to “Response from Biogen”

I’m impressed that you actually received not only a response, but a *timely* response. What are your thoughts about this? I guess I hadn’t considered that releasing the results could affect FDA approval – although I’m still not sure how it would.-S